Lead Consultant, Clinical Operations

Boston

 

Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively and push beyond the status quo? Join Halloran Consulting Group, Inc. today!

Halloran is looking for a Lead Consultant to join its Clinical Operations practice area. As a Lead Consultant, Clinical Operations, you will manage multiple clinical programs for development stage biotech, pharmaceutical, and medical device companies to guide, develop, and advice on operational strategies. You will lead development of study strategies and plans and lead implementation, and mentor junior level consultants.

 

Characteristic Duties:
  • Independently manage multiple clinical trials for biotech/pharma sponsor companies
  • Establish project-related expectations, alignment of roles and responsibilities, and management of assigned projects to plan and budget
  • Lead development of protocol synopses, protocols, and ICFs; identify alternative study designs for efficiencies in cost/time
  • Lead study planning activities including outlining operational strategies and assumptions to develop comprehensive timelines, budgets, study management plans, and risk mitigation plans based on GCP, regulatory guidelines, best clinical practice, and the competitive clinical landscape
  • Lead CRO/vendor selection processes, develop and manage vendor oversight plans, and manage CROs, vendors, and cross-functional team members on behalf of clients
  • Independently manage all aspects of study management, development of study tools, training materials, recruitment plans, reports, timelines and other critical study deliverables
  • Proactively identify, mitigate, and raise awareness to project risks; ensure timely issue resolution
  • Provide ongoing updates to stakeholders via dashboards, presentations, and other appropriate communication methods
  • Support clinical related process optimization initiatives and other Halloran practice area projects as a clinical subject matter expert
  • Participate in internal activities such as publishing articles, presenting/moderating workshops, and attending conferences when opportunities arise
  • Mentor internal Halloran team members (up, down, and across the organization) to ensure success of company and client goals
  • Contribute to business development efforts, including the authoring of proposals for new client engagements and identifying business development opportunities in existing clients and educating clients on Halloran Services
  • Other duties and responsibilities as assigned

 

Qualifications:

Required:

  • Bachelor’s Degree in a scientific discipline and a minimum of ten years of related experience, including a minimum of six years of experience in a biotech or pharma setting managing clinical studies and CROs
  • Ability to work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
  • Exercise judgment in selection methods, techniques and evaluation criteria for obtaining results
  • Network with key contacts outside own area of expertise

 

Halloran Consulting Group, Inc. Perks:
  • Comprehensive Medical, Dental, and Vision Insurance
  • 401(k) Plan for all Full-Time Employees
  • Reimbursements for Health & Wellness Programs and Memberships
  • Opportunities for Internal and External Learning through Conference Attendance and Tuition Reimbursement
  • Self-Managed PTO Policy
  • Commuter FSA Benefits

 

Notice:

Our company is committed to equal employment opportunity.  We will not discriminate against employees or applicants for employment based on any protected class including, but not limited to race, color, religious creed, national origin, sex, pregnancy, sexual orientation, ancestry, age [over 40], veteran status, genetic information, disability, gender identity and expression, citizenship status, handicap, military membership or any other legally-protected characteristic.

Halloran Consulting Group | Lead Consultant, Clinical Operations